MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA TAPER LINER GG / 32; CERAMIC ACETABULAR LINER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Six month history of groin-hip flexor pain on straight leg raise and walk was reported.The patient developed the symptoms between the 7 and 10 year follow up.No further outcome has been reported.The devices remain implanted.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Medical device: biolox⮠delta, ceramic femoral head, s, 㸠32/-3.5, taper 12/14; item# 00877503201; lot# 2587282 48mm o.D.Size gg porous uncemented with cluster holes shell use with gg liners; item# 00875704801; lot# 61774209.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 10 standard offset; item# 65771101000; lot# 61566509.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00365.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided: product evaluation could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical records were provided and reviewed by a health care professional which confirmed the reported event.Ultrasound shows no tendinopathy, x-ray normal, patient participates in moderate activity, satisfied with hip, and does unlimited walking.Mri scan ordered as doctor states may be referred pain from lumbar spine.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA TAPER LINER GG / 32
• Common Device Name: CERAMIC ACETABULAR LINER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14942295
• Report Number: 0009613350-2022-00366
• Device Sequence Number: 6215519
• Product Code: LPH
• UDI-Device Identifier: 00889024430310
• UDI-Public: (01)00889024430310(17)210131(10)2580686
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-008-32
• Device Lot Number: 2580686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 62 KG